Advanced Pancreatic AdenocarcinomaPhase 1NCT01050283
A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
A Phase 1 study testing Comparator: [18F]-FDG PET/CT and Volumetric CT in people with Advanced Pancreatic Adenocarcinoma, run by Merck Sharp & Dohme LLC.
Trial summary
This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Advanced Pancreatic Adenocarcinoma
- What is being tested?
- Comparator: [18F]-FDG PET/CT and Volumetric CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jul 2010to May 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
- Patient is scheduled to receive standard chemotherapy containing gemcitabine
- Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
- Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution
Who cannot join
- Patient has had open abdominal surgery within 6 weeks of the screening visit
- Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
- Patient has an active infection, inflammation, or unresolved bowel obstruction
- Patient has poorly controlled diabetes
About this study
Official title: A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity
This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.
- Conditions
- Advanced Pancreatic Adenocarcinoma
- Being tested
- Comparator: [18F]-FDG PET/CT and Volumetric CT
- Keywords
- Advanced pancreatic adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: [18F]-FDG PET/CT and Volumetric CTProcedure or surgery
Patients will receive gemcitabine-based therapy as prescribed by their treating physician. FDG-PET/CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. Volumetric CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | [18F]-FDG-PET/CT (Computed Tomography) Imaging Receives: Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of changes in FDG uptake with overall survival (OS)
Measured: Week 3 and at least 7 months after the last patient is treated
Secondary outcomes (2)
Association of metabolic response with OS
Measured: Baseline, Week 3, and at least 7 months after the last patient is treated
Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7
Measured: Week 3 and Week 6-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050283
- Sponsor's protocol ID
- 0000-144
- Other IDs
- 144
- Status last verified
- Jul 2015
- First submitted
- 13 Jan 2010
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity
- ClinicalTrials.gov ID
- NCT01050283
- Acronym / sponsor ID
- 0000-144
- Conditions
- Advanced Pancreatic Adenocarcinoma
- Keywords
- Advanced pancreatic adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT[18F]-FDG-PET/CT (Computed Tomography) Imaging |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
- Patient is scheduled to receive standard chemotherapy containing gemcitabine
- Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
- Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution
Key exclusion criteria (4 listed)
- Patient has had open abdominal surgery within 6 weeks of the screening visit
- Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
- Patient has an active infection, inflammation, or unresolved bowel obstruction
- Patient has poorly controlled diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator: [18F]-FDG PET/CT and Volumetric CTPatients will receive gemcitabine-based therapy as prescribed by their treating physician. FDG-PET/CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. Volumetric CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. | Procedure or surgery | 1 |
Primary outcome
Association of changes in FDG uptake with overall survival (OS)
Time frame: Week 3 and at least 7 months after the last patient is treated
2 secondary outcomes
Association of metabolic response with OS
Time frame: Baseline, Week 3, and at least 7 months after the last patient is treated
Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7
Time frame: Week 3 and Week 6-7
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Comparator: [18F]-FDG PET/CT and Volumetric CT in people with Advanced Pancreatic Adenocarcinoma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of changes in FDG uptake with overall survival (OS) (time frame: Week 3 and at least 7 months after the last patient is treated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015.